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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC PINNACLE; CERAMIC ACETABULAR LINER

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DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC PINNACLE; CERAMIC ACETABULAR LINER Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER CERAM
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Joint Dislocation (2374)
Event Date 03/21/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).D4: the device catalog number is unknown; therefore, udi is unavailable.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Literature article entitled "change of pelvic sagittal tilt after total hip arthroplasty in patients with bilateral crowe type iv developmental dysplasia of the hip " written by bohan zhang, md, yinqiao du, md, jingyang sun, md, junmin shen, md, tiejian li, md, yonggang zhou, md, phd published by orthopaedic surgery accepted on (b)(6) 2022 was reviewed.The article's purpose was to explore and analyze the change of pelvic sagittal tilt (pst) after total hip arthroplasty (tha) in patients with bilateral crowe type iv developmental dysplasia of the hip (ddh).The study retrospectively evaluated 43 patients with bilateral crowe type iv ddh undergoing tha from (b)(6) 2008 to (b)(6) 2019 who were followed up for 12 months postoperatively.The significant change of pelvic sagittal posterior tilt in patients with bilateral crowe type iv ddh might be a significant phenomenon after tha, which could occur in 6 months postoperatively.All patients utilized the s-rom modular cementless prosthesis and the cementless acetabular cup of ceramic on ceramic bearing (pinnacle) from depuy synthes.The article details 3 post-surgical complications including two hip dislocations requiring open reductions.A periprosthetic fracture of the right femur occurred in one hip as well, treated via open reduction and enhanced internal fixation.All patients recovered with no further complications.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
 
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Brand Name
UNK HIP ACETABULAR LINER CERAMIC PINNACLE
Type of Device
CERAMIC ACETABULAR LINER
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS 1818910
700 orthopaedic dr
warsaw IN 46581 0988
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key17161680
MDR Text Key317632489
Report Number1818910-2023-12511
Device Sequence Number1
Product Code MRA
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER CERAM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/31/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received06/22/2023
Supplement Dates FDA Received06/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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